COVID-19 vaccine development pipeline gears up

[gracielle]

Plitidepsin found to work better than remdesivir for treating COVID-19

A large team of researchers affiliated with a host of institutions in the U.S., France and Spain has found that the drug plitidepsin worked better at treating COVID-19 than did remdesivir in a lab setting. In their paper published in the journal Science, the group describes their study of the...

medicalxpress.com

Plitidepsin Shows Promise against SARS-CoV-2 in Preclinical Models

Working in preclinical models, researchers report that plitidepsin is more potent against SARS-CoV-2 than remdesivir.

www.genengnews.com

 

[jeff1234]

UPDATE: 29 January 2021

Covid vaccine: Single-dose Johnson & Johnson jab is 66% effective

An international trial shows the jab gives complete protection against hospitalisation and death.

www.bbc.com

'Simple is beautiful': One-shot vaccine proves effective

The first one-shot COVID-19 vaccine provides good protection against the illness, Johnson & Johnson reported in a key study released Friday, offering the world a potentially important new tool as it races to stay ahead of the rapidly mutating virus.

medicalxpress.com

Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe disease, company says | CNN

Johnson & Johnson's Covid-19 single-shot vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.

edition.cnn.com

 

[antipodean]

Llegó a Chile el avión con casi 2 millones de dosis de la vacuna china

Este envío será sucedido por un segundo que Sinovac realizará el 31 de enero al país vecino con una cantidad similar de dosis, para comenzar a cumplir con el contrato que garantiza diez millones de vacunas para el país.

www.cronista.com

Chile just received two million doses from China on one flight. More of the 10 million ordered are on the way on 31JAN. Not bad for a country of 18 million where so far only about 60.000 have received the Pfizer vaccine.

 

[gracielle]

28 January 2021....see translation of this article on Page 61.

Cómo será la vacuna argentina contra el coronavirus | El Conicet trabaja en base a un método innovador que consiste en inocular una proteína para que el cuerpo produzca los anticuerpos

En declaraciones al programa #Caimialaseis que se emite por AM750, el ministro de Ciencia Roberto Salvarezza explicó los detalles del diseño del antídoto de producción nacional que el organismo científico está desarrollando junto a la Universidad del L...

www.pagina12.com.ar

UPDATE:

Vacuna argentina contra el coronavirus: ¿en qué fase está la tecnología local? | Ya está por finalizar la etapa preclínica y el objetivo es iniciar la prueba en humanos

Es desarrollada por la Universidad Nacional de San Martín y está basada en proteínas recombinantes. Además, hay un segundo proyecto de la Universidad Nacional del Litoral. La palabra de uno de los investigadores a cargo y del ministro Roberto Salvarezza.

www.pagina12.com.ar

29 January 2021
The preclinical stage is about to end and the goal is to start the human trial.
Argentine vaccine against coronavirus: what phase is the local technology in?
....“The vaccine has been working very well. The preclinical phase with animals is about to be completed and the next step will be to move towards clinical trials in humans. Now what we are looking at is how to partner with a laboratory capable of scaling production. You have to think that for scale tests in humans a company is required that can produce the product ", says Juan Ugalde, doctor in Molecular Biology and Biotechnology, dean of the Institute of Biotechnological Research of the National University of San Martín in charge of the project.

....the Agency led by Fernando Peirano was working very hard to make an agreement. There is little left, we are close to a partner that can produce this protein, which will be the basis of the technology ”. And, along these lines, he continues: “In addition to the project of the National University of San Martín, there is that of the National University of the Litoral that we also finance....

....Science as a path to sovereignty. “There is no doubt that Argentine science is capable of producing vaccines. The clearest case is that of mAbxience, which manufactures the active substance for Oxford/AstraZeneca. Now, what we were also looking for is to show that we are also capable of designing a vaccine from the beginning, of constituting the platform and not just producing it at scale. Here come the contributions that Conicet and the national universities are making ”, emphasizes Salvarezza....

....although there are no definitive deadlines for the production locally and even if the help of neighboring businessmen or nations of other continents with large biotechnological plants for its manufacture at scale is required, the development of its own vaccine is still excellent news....

....To make a vaccine you need money. In mid-2020, the Unsam group and the Universidad Nacional del Litoral had received a subsidy close to 100,000 dollars from the Covid Unit, made up of Conicet, MinCyT and the National Agency for the Promotion of Research, Technological Development and Innovation. However, despite the initial push, reality indicates that much more capital is required. Along these lines, the alliances that can be established will play a decisive role....There are many advanced conversations with interested companies, but it is not possible to disclose anything so far ”, warns Ugalde....

 

[gracielle]

CanSino to submit vaccine trial results to Mexico next week

China's CanSino Biologics Inc will submit the results of clinical trials for its COVID-19 vaccine to Mexican authorities next week, a top health official said on Tuesday, marking another step toward its potential approval in the country.

www.reuters.com

Russia may give China's CanSino vaccine first global approval

(Jan 15): CanSino Biologics Inc.’s Russian partner expects local authorities to register the Chinese company’s Covid-19 vaccine soon, potentially marking the first approval for use of the inoculation outside of China.“All registration procedures have been completed, we expect to get the...

www.theedgemarkets.com

 

[gracielle]

Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa (Published 2021)

An early analysis in Britain found that the vaccine had an efficacy rate of nearly 90 percent. But in a small South Africa trial, the efficacy rate dropped to just under 50 percent.

www.nytimes.com

What is the Novavax vaccine, and how does it work?

Novavax's subunit vaccine approach is a tried and true method for generating effective vaccines.

qz.com

Science | AAAS

www.sciencemag.org

UPDATE: 30 January 2021

Novavax COVID-19 vaccine news welcomed in South Africa

News that the Novavax COVID-19 vaccine has shown about 60% efficacy on HIV-positive patients and that it seems to work against the variant of the virus now dominant in South Africa is being welcomed with relief in the country, but further studies are urged.

medicalxpress.com

 

[gracielle]

COVID-19 updates: Anti-vaccine protesters halt vaccinations at Dodger Stadium

A pandemic of the novel coronavirus has now infected more than 102 million people worldwide and killed over 2.2 million of them.

abcnews.go.com

31 January 2021
COVID live updates: South African variant....One case has been confirmed in Maryland; two were found in South Carolina....

30 January 2021
California is now the second U.S. state with known detection of the Brazil P.1 variant. Minnesota health officials confirmed earlier this week the nation's first known COVID-19 case associated with the variant.

Inside Stanford's Clinical Virology Laboratory, Dr. Benjamin Pinsky and his team found two strains of the virus: the Brazil strain and the U.K. strain, KGO Bay Area and SF news station reported Saturday morning. "It's in about 17% of the samples that we've sequenced," Pinsky told KGO.

 

[gracielle]

Coronavirus: qué vacunas negocia el Gobierno para febrero tras la demora de la Sputnik V

Coronavirus: qué vacunas negocia el Gobierno para febrero tras la demora de la Sputnik V

www.lanacion.com.ar

31 January 2021....By: Maia Jastreblansky
Coronavirus: what vaccines the Government negotiates for February after the delay of Sputnik V.
....The Government hoped to end the first month of the year with almost five million Sputnik Vs in the country, launch mass vaccination and win a first battle against the pandemic. It could not be....

....In the last hours of this week, however, several officials returned to rebuild the spirit: as LA NACION was able to reconstruct, the silent expectation that is housed in official offices is that Russia will make a "fine tunning" with its deliveries in February and that a million Chinese vaccines will also arrive during the next month. Some even believe that the first doses of AstraZeneca, scheduled for March, could be brought forward.

The government negotiates against the clock the vaccine from Sinopharm, China's state pharmaceutical company. It would be a million doses. The talks are strongly supported by the performance of the new ambassador in Beijing, Sabino Vaca Narvaja. At some point, the Government estimated that it could have had this vaccine in January, but the negotiations took longer than expected. LA NACION learned that the ANMAT still needs to receive more information to approve it and that it remains to "adapt the terms of the contract to local legislation." The other obstacle that arises is that the Chinese New Year is February 12, and in the Casa Rosada they fear that this will also delay delivery by a few days. But unlike the Russian case, Sinopharm's vaccines are already manufactured, and that is what fuels official expectations.

The Oxford-Astrazeneca vaccine -whose active ingredient was manufactured in Argentina by the Insud laboratory and has already been sent to Mexico for dosage, packaging and certification- scheduled its deliveries for March. The Government has the following schedule: 1.1 million in March, 4.6 million in April, 4.6 million in May, 3.4 million in June and 8.5 million in July. Last week, Hugo Sigman, the head of the Insud laboratory, was at the Casa Rosada. After his visit, the officials were excited at the thought that they may have a first lot in the coming weeks.

The Russian case....The transition to scale production of the vaccine created by the Gamaleya Institute exhibited difficulties. The undisclosed reason is that after the transfer of technology to the production centers in South Korea and India, it made quality controls more complex: Russia cannot allow itself a mistake on the medical side, because it fears that the Western world will not forgive it. It was thus that Putin could not comply with the agreement with the Alberto Fernández administration. "We perceive that it even afflicted them, working a thousand hours a day and expressing a lot of commitment to us," an official who closely follows the inexhaustible videoconferences conducted by the two women appointed by the President to run the world marathon for the vaccine: the secretary of Access to Health, Carla Vizzotti and the presidential advisor, Cecilia Nicolini.

In the last hours, these officials discussed with the Russian Investment Fund (RDIF) the possibility of "re-profiling" a delivery schedule "as realistic as possible." As LA NACION was able to reconstruct, the Russian authorities proposed to the Government a "catch up" to relatively get deliveries with a delay of three or four weeks. "We are working with a readjustment of the schedule as realistic as possible. The maximum objective remains that the delivery of the 20 million vaccines is completed by the end of March," said an important official collaborator.

"European countries are evaluating initiating legal action against laboratories, what happened to us happens all over the world," an important minister was satisfied at the end of this week. Fernández does not even think of suing the RDIF. "It would be like shooting yourself in the foot," they say near him. Relations are good, because the Argentine case would have functioned for Vladimir Putin to make his way in other Latin American countries.

Other vaccines....The other contract that Argentina has already signed, the Covax Initiative, would bear fruit further in time. Through this mechanism, which distributes vaccines among a consortium of countries, Argentina was committed 9 million doses, but there is still no delivery date.

The other negotiations in Argentina with a certain vitality are those carried out with the Chinese-Canadian association CanSino Biologics and with the North American Moderna. But these laboratories offer to supply Argentina "only in the third quarter of this year," official sources indicated.

With Sinovac, the Chinese laboratory that delivered two million doses to Chile this week, and which closed agreements with Brazil and Colombia, the talks are cold, an official source acknowledged. With Pfizer, the negotiations were in a legal limbo: the Legal and Technical Secretary, Vilma Ibarra, had an approach with the executives of the Argentine subsidiary, after the negotiations were bogged down by the vaccine law. There were no new advances. "We do not want to be the ones to close the door," a high-ranking official told LA NACION in the last hours about the vaccine that was at the forefront of the Western world.

"In each negotiation there are three axes: the approval of phase III, the negotiation of the legal aspects of the contract and the delivery schedule," summarized an official. The new goal they set in Fernández's surroundings (and that they avoid aloud) is "to reach the fall with the 12 million people who make up the vaccinated priority groups." Without the doses expected for January, the Government's GPS was forced to recalculate the roadmap.

 

[antipodean]

Coronavirus: qué vacunas negocia el Gobierno para febrero tras la demora de la Sputnik V

Coronavirus: qué vacunas negocia el Gobierno para febrero tras la demora de la Sputnik V

www.lanacion.com.ar

31 January 2021....By: Maia Jastreblansky
Coronavirus: what vaccines the Government negotiates for February after the delay of Sputnik V.
....The Government hoped to end the first month of the year with almost five million Sputnik Vs in the country, launch mass vaccination and win a first battle against the pandemic. It could not be....

....In the last hours of this week, however, several officials returned to rebuild the spirit: as LA NACION was able to reconstruct, the silent expectation that is housed in official offices is that Russia will make a "fine tunning" with its deliveries in February and that a million Chinese vaccines will also arrive during the next month. Some even believe that the first doses of AstraZeneca, scheduled for March, could be brought forward.

The government negotiates against the clock the vaccine from Sinopharm, China's state pharmaceutical company. It would be a million doses. The talks are strongly supported by the performance of the new ambassador in Beijing, Sabino Vaca Narvaja. At some point, the Government estimated that it could have had this vaccine in January, but the negotiations took longer than expected. LA NACION learned that the ANMAT still needs to receive more information to approve it and that it remains to "adapt the terms of the contract to local legislation." The other obstacle that arises is that the Chinese New Year is February 12, and in the Casa Rosada they fear that this will also delay delivery by a few days. But unlike the Russian case, Sinopharm's vaccines are already manufactured, and that is what fuels official expectations.

The Oxford-Astrazeneca vaccine -whose active ingredient was manufactured in Argentina by the Insud laboratory and has already been sent to Mexico for dosage, packaging and certification- scheduled its deliveries for March. The Government has the following schedule: 1.1 million in March, 4.6 million in April, 4.6 million in May, 3.4 million in June and 8.5 million in July. Last week, Hugo Sigman, the head of the Insud laboratory, was at the Casa Rosada. After his visit, the officials were excited at the thought that they may have a first lot in the coming weeks.

The Russian case....The transition to scale production of the vaccine created by the Gamaleya Institute exhibited difficulties. The undisclosed reason is that after the transfer of technology to the production centers in South Korea and India, it made quality controls more complex: Russia cannot allow itself a mistake on the medical side, because it fears that the Western world will not forgive it. It was thus that Putin could not comply with the agreement with the Alberto Fernández administration. "We perceive that it even afflicted them, working a thousand hours a day and expressing a lot of commitment to us," an official who closely follows the inexhaustible videoconferences conducted by the two women appointed by the President to run the world marathon for the vaccine: the secretary of Access to Health, Carla Vizzotti and the presidential advisor, Cecilia Nicolini.

In the last hours, these officials discussed with the Russian Investment Fund (RDIF) the possibility of "re-profiling" a delivery schedule "as realistic as possible." As LA NACION was able to reconstruct, the Russian authorities proposed to the Government a "catch up" to relatively get deliveries with a delay of three or four weeks. "We are working with a readjustment of the schedule as realistic as possible. The maximum objective remains that the delivery of the 20 million vaccines is completed by the end of March," said an important official collaborator.

"European countries are evaluating initiating legal action against laboratories, what happened to us happens all over the world," an important minister was satisfied at the end of this week. Fernández does not even think of suing the RDIF. "It would be like shooting yourself in the foot," they say near him. Relations are good, because the Argentine case would have functioned for Vladimir Putin to make his way in other Latin American countries.

Other vaccines....The other contract that Argentina has already signed, the Covax Initiative, would bear fruit further in time. Through this mechanism, which distributes vaccines among a consortium of countries, Argentina was committed 9 million doses, but there is still no delivery date.

The other negotiations in Argentina with a certain vitality are those carried out with the Chinese-Canadian association CanSino Biologics and with the North American Moderna. But these laboratories offer to supply Argentina "only in the third quarter of this year," official sources indicated.

With Sinovac, the Chinese laboratory that delivered two million doses to Chile this week, and which closed agreements with Brazil and Colombia, the talks are cold, an official source acknowledged. With Pfizer, the negotiations were in a legal limbo: the Legal and Technical Secretary, Vilma Ibarra, had an approach with the executives of the Argentine subsidiary, after the negotiations were bogged down by the vaccine law. There were no new advances. "We do not want to be the ones to close the door," a high-ranking official told LA NACION in the last hours about the vaccine that was at the forefront of the Western world.

"In each negotiation there are three axes: the approval of phase III, the negotiation of the legal aspects of the contract and the delivery schedule," summarized an official. The new goal they set in Fernández's surroundings (and that they avoid aloud) is "to reach the fall with the 12 million people who make up the vaccinated priority groups." Without the doses expected for January, the Government's GPS was forced to recalculate the roadmap.

Why am I getting the feeling that Argentina is about to fall deadfully behind in the immunization race in 2021, just as it did with infection rates and fatalities in 2020 due to a tendency of counting their chickens before they have hatched and placing too many eggs in one basket.

Some of our neighbors have shown that if there is a serious and diligent effort made then there is a way to get vaccines, yet all we get are excuses and as a result, very few vaccines after the initial fanfare.
- Brazil - 2m doses administered
- Chile - 67k doses administered with 2m+ now onshore, available and being administered

 

[gracielle]

Nuevos inconvenientes con la vacuna Sputnik V: los laboratorios de India y Corea del Sur que la producen no tienen aún a la Argentina en sus planes de exportación

González García se reunió con los embajadores de ambos países. En uno de ellos la vacuna rusa recién comenzó la experimentación en fase 3 y el otro no despachará nada hasta que concluya su propia campaña de inmunización, que empieza mañana

www.infobae.com

31 January 2021....by Silvia Mercado
New problems with the Sputnik V vaccine: the laboratories in India and South Korea that produce it do not yet have Argentina in their export plans.

González García met with the ambassadors of both countries. In one of them, the Russian vaccine has just started the experimentation in phase 3 and the other will not dispatch anything until it concludes its own immunization campaign, which begins tomorrow.

Ginés González García seems determined to use formal diplomatic channels so that the arrival of vaccines in Argentina progresses with fewer short-circuits than those found so far with the Russian Fund for Direct Investment, which was also in charge of signing the contracts with the laboratories in India and South Korea that are manufacturing the Sputnik V vaccine. The Minister of Health went to meet the ambassadors of both countries. He got together with Dinesh Battia on Wednesday January 21 and last Thursday he met with Jang Myung-soo.

González García thanked the Korean for the donation that his country made to Argentina of 447,000 masks equivalent to the N95 model for a value of 300 thousand dollars, for use by health personnel. It was "a sign of the enormous mutual affection and commitment between the two countries." "It is a relationship that we want to improve, expand and make it much more productive for the health and well-being of our peoples," stated the press release that was issued.

Both India and Korea "are countries that play an important role in the production of vaccines against COVID-19," added the Health Ministry. It is something that Argentines know very well. RDIF communications insistently repeat that Sputnik V will come from those countries, contracted by Argentina to the Russians. Although no one has yet explained when they will come, or what the conditions will be for these exports to materialize. They did not clarify it to González García either.

"In the meeting we had with the Minister, we did not talk about Sputnik V, because our government has just announced our vaccination plan that begins in February, so it is too early to talk about vaccine exports to other countries," told to INFOBAE by an authorized spokesperson for the Seoul embassy in Argentina. Nor could Dinesh Battia, the representative of India in Buenos Aires, a country that "has special significance in the management of the pandemic, since it is one of the large producers of vaccines", as expressed by the Health Ministry in its release.

Dr. Reddy's Laboratory, the company that signed the contract with the Russian Fund to produce Sputnik V, is a pharmaceutical giant listed on the New York Stock Exchange and has the motto "Good health cannot wait" (Good Health Can't Wait). It is perhaps the best positioned company in the manufacture of generics and the most capable in the world to produce fast and at low costs. "Sputnik V is not yet approved in India by the regulatory authorities, so we cannot know where Dr. Reddy's is going to export," Ambassador Battia said before a query from this reporter, who positively evaluated the meeting he had with González García and anticipated that "we are exploring possibilities" with Argentina.

Dr. Reddy's Laboratories (DRL) just received on January 15 approval from the regulatory body, the General Drug Control of India (DCGI), to carry out the phase 3 clinical trial for the Russian vaccine, which will be carried out in 1,500 people as part of the randomized, “double-blind, parallel-group, placebo-controlled study from India,” the company reported in a very recent statement.

India is a large producer of medicines and vaccines with its own research, it does not only manufactures façon (by order of third parties). In August 2020, it constituted a National Expert Group for the Administration of the Vaccine against COVID-19 with the aim of coordinating the contracting and distribution of vaccines, and reported the projects it has advanced, which are basically three.

On the one hand, Covaxin, developed by Bharat Biotech in association with the Indian Council for Medical Research (CMR, in English). Second, ZyCOV-D, developed by Zydus Cadila, which expects to produce more than 100 million doses. And finally, Covishield, a project of the Serum Institute of India that collaborates with AstraZéneca to develop original research from the University of Oxford.

A façon, in addition to the Sputnik V being produced by Dr. Reddy’s Laboratories (DRL), the Indian pharmaceutical company Biological E is in the process of manufacturing the vaccine Janssen Pharmaceutica NV, which is a subsidiary of Johnson & Johnson.

On January 20, the Prime Minister reported that vaccine exports to Brazil, Morocco and Bangladesh have already been completed, and he anticipates future commercial shipments to Saudi Arabia, South Africa, Canada and Mongolia. Nothing said about Argentina.

He also detailed the donation of 5,500,000 vaccines that have already being made for its neighboring or geographically close countries, Bhutan, Maldives, Nepal, Bangladesh, Myanmar, Mauritius, Seychelles, Sri Lanka and Bahrain. And that it plans to extend the donations to other countries such as Oman, CARICOM nations, Nicaragua and Pacific Island States. And the contribution to the COVAX Initiative.

Finally, he clarified that "our external supplies, whether as a gift or commercial, are based on national availability" and "of course, depending on the needs of the deployment of the COVID-19 vaccine in the country."

"The largest deliveries are going to be from India and South Korea," said Pablo Ceriani in statements to journalist Nicolás Pizzi, from INFOBAE. González García himself had said something similar: "They will not come from Russia, they will come from India and Korea." They were expected to be between 800 thousand and 1 million for each plane, for which the corresponding permits were being processed, which would facilitate the authorization that barely reached 600 thousand doses per flight.

The only thing missing was who produces the vaccines. In the plans of India and South Korea, Argentina still does not figure.